Lipitor has had a generic version of itself, made by Ranbaxy Pharmaceuticals Inc., approved for sale by the FDA.
Ranbaxy’s drug, Atorvastatin, is the generic equivalent of the cholesterol-reducing brand Lipitor, which is manufactured by Teva Pharmaceuticals USA Inc., reports Bloomberg.
During the six-month period, a portion of the profits from sales of Atorvastatin will be paid to Teva Pharmaceuticals.
Terms of the agreement will not be disclosed, a news release said. Teva Pharmaceutical Industries Ltd., based in Israel, is the world's largest generic pharmaceutical company.
Jacksonville-based Ranbaxy Pharmaceuticals Inc. is a subsidiary of Ranbaxy Laboratories Ltd, which is based in India and is India's largest generic drug manufacturer.
Arun Sawhney, CEO and managing director of Ranbaxy, said in a statement, “Atorvastatin helps millions of Americans manage healthy cholesterol levels,” Reuters reports.
“We are pleased to have received U.S. FDA approval to manufacture and market a safe, effective, affordable and accessible alternative to branded Lipitor,” he added.
Through to September 2011, Lipitor, which lost patent protection last week, generated total annual sales of $7.8 billion in the U.S.
Commenting on its approval of Ranbaxy’s application, the FDA said it is working “very hard” to make generic drugs available to Americans, reports Reuters.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement, “This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options.”
